Events

Pharmacovigilance System Master File

This course is led by John Barber, Head of Pharmacovigilance - European Operations at Dr Reddy's Laboratories (UK) and facilitated by Dora Amene, Drug Safety Officer, Reckitt Benckiser UK Commercial Ltd.

The agenda includes:

History & evolution of the PSMF

Background discussion into how the PSMF came to be.

Discussion of previous equivalent documents

What is the PSMF & what is the legislation?

An overview of the current EU legislation regarding the PSMF

The PSMF and the rest of the world

Brief introduction to the structure of the PSMF

Structure of the PSMF

An overview of the structure of the body of the PSMF

Workshop 1 - Considerations for drafting a PSMF module

PSMF Annexes and PSMF Maintenance

Discussion about strategies to maintain and update various sections of the PSMF to ensure the document is reflective of the PV system.

Workshop 2 - Considerations for drafting an annex

Inspection Findings related to the PSMF

Discussion of some of the inspection findngs and deficiencies related to the structure and maintenance of the PSMF.

Workshop 3 – PSMF SOP & Challenges

Strategies for planning, writing, maintaining and updating the PSMF.

Draft the structure of a PSMF SOP and discuss the critical points that should be included.

Target audience: Anyone involved in compiling and maintaining the PSMF